Ambika Choudhary, PharmD, MS Regulatory Affairs

• Led a cross-functional team of 5 to prepare regulatory submissions for Class II medical device, supporting Health Canada and FDA submissions. • Authored 4 SOPs and developed Health Canada submission checklist, cutting document turnaround time by 25%. • Drafted responses to Health Canada ITA queries and submitted a pre-submission meeting request accelerating the regulatory feedback loop. • Developed labeling and packaging, fully aligned with SOR/98-282, FDA and ISO 15223-1 labeling requirements ensuring 100% audit readiness. • Applied regulatory intelligence to ensure labeling compliance across U.S. and Canada markets, accelerating submission timelines by 4 weeks.

• A Assisted in preparation and submission of regulatory documents (Pre-Sub, 510(k)s, PMAs, NDAs, MAAs, CTAs, INDs, IDE) in eCTD format to obtain product registration/ approval for class II and III medical devices. • Drafted and reviewed 25+ regulatory documents (technical files, letter to file, annual reports, supplements, amendments, meeting packages). • Developed regulatory strategies for new products/therapies and provided regulatory support for changes to existing products. • Drafted responses to questions from regulatory agencies, improving response accuracy and reduced review cycles by 30%. • Prepared product labeling, package inserts, IFUs, SSEs for 5+ medical devices, ensuring zero deficiencies on first submission. • Developed CRFs, ICFs, study reports, IBs, SOP ensuring 100% compliance with GCP and regulatory standards for clinical trials. • Stayed updated with regulations, laws, guidelines and standards and ensured compliance with FDA and international regulatory requirements.

• Led a team of 10 to develop EU MDR compliant UDI Standard Operating Procedure (SOP) for Class IIa medical device. • Integrated UDI-DI and UDI-PI elements within the SOP, to support the company’s CE mark transition from MDD to MDR certification improving documentation quality by 40%. • Ensured compliance with QMS and risk-based requirements across UDI documentation, ensuring 100% audit readiness for notified body review. • Led gap analyses, maintained regulatory documentation to streamline regulatory submissions and support product lifecycle management.

• Authored 10+ scientifically accurate, well-referenced deliverables including case studies, summaries, manuscripts, abstracts, posters and presentations across multiple therapeutic areas, driving 100% acceptance rate. • Conducted in-depth literature review using PubMed, Elsevier and google scholar to support evidence based clinical and promotional material. • Translated complex clinical data into clear, engaging targeted content, increasing HCP engagement by 30%. • Collaborated with a U.S.-based physician to publish a high-quality rare disease case report, adhering to ICMJE and AMA style.

• Supported clinical trial operations for 3 clinical trials from supporting IRB submissions through data collection and protocol compliance. • Drafted and reviewed 10+ clinical trial documents including ICFs, CRFs, CSRs, IBs, safety reports, ensuring 100% GCP and ICH compliance. • Implemented efficient participant recruitment strategies, streamlined patient recruitment and informed consent process, reducing enrollment timelines by 20% and improving enrollment efficiency by 30%. • Reported adverse events and maintained trial related documents and TMFs, contributing to zero major findings during internal audits.

● Co-developed educational materials in collaboration with Monash University, resulting in a 30% improvement in comprehension rates among participants. ● Facilitated discussions and encouraged critical thinking skills, fostering an engaging learning environment. ● Demonstrated expertise in pharmacology and therapeutics, providing detailed solutions and guidance to enhance student learning experiences.

● Provided subject matter expertise and guidance to students in the field of Pharmacology and therapeutics, enhancing their learning experiences. ● Demonstrated strong communication skills and the ability to convey complex concepts in an understandable manner. ● Contributed to the academic success of students by providing detailed solutions and guidance.

● Recipient of CPS Leaders and Scholars Award. ● Relevant Coursework: Regulatory Compliance Practice, Product Development, and Life Cycle Management Strategies, FDA Biopharmaceuticals and Medical Device Regulation, Safety Sciences, Fundamentals of CMC, Human Experimentation: Fundamentals of Clinical Trials

● Gold Medalist of Batch 2017-2023. ● Awarded the Unique Student Award in the postgraduate category during APP 10th Annual International Virtual Convention. ● Completed the research project "Evaluation of Pharmacoeconomics of Statins in Cardiovascular Diseases: A Multicentric Cross-Sectional Study" aimed at evaluating the utilization, effectiveness, and burden of statins among patients with cardiovascular diseases. ● Leading member of Pharmacy college writing committee. ● Corresponding author of multiple publications in scientific journals. ● Relevant coursework: Pharmacology, Pathophysiology, Anatomy and Physiology, Medicinal Chemistry, Pharmaceutics, Formulations, Pharmacotherapy, Pharmacokinetics, Pharmacodynamics, Clinical Pharmacy Practice, Pharmacy Law and Ethics, Biostatistics and Research Methodology, Patient Counseling and Communication, Microbiology, Clinical toxicology, Pharmacoepidemiology & Pharmacoeconomics, Clinical research, drug monitoring.